Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of stent struts with late acquired malaposition
研究概览
简要总结
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
详细描述
please see brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES
排除标准
- •chronic renal failure (serum creatinine ≥ 2.5mg/dl)
- •restenotic lesions
研究组 & 干预措施
Everolimus-Eluting-Stent (EES)
Patients treated with EES
干预措施: Everolimus-Eluting Stent (EES) (Procedure)
Zotarolimus-Eluting-Stent (ZES)
Patients treated with ZES
干预措施: Zotarolimus-Eluting-Stent (ZES) (Procedure)
Biolimus-Eluting-Stent (BES)
Patients treated with BES
干预措施: Biolimus-Eluting-Stent (BES) (Procedure)
结局指标
主要结局
Number of stent struts with late acquired malaposition
时间窗: 1 year after stent implantation
次要结局
- number of stent struts with late acquired malaposition(2 years after stent implantation)
研究者
Univ. Prof. Dr. Thomas Neunteufl
Univ. Prof. Dr.
Medical University of Vienna